Does TechSert manage Roszdravnadzor registration for medical devices?

No. TechSert focus is on technical (EAC, RoHS) and sanitary (SGR, Cosmetics) compliance for free commercial circulation within the EAEU. We do not manage the clinical ministerial process for high-class medical devices.

Can aesthetic machinery and their associated cosmetics be certified together?

Yes. TechSert offers an integrated approach to certify the entire sales package, including the device (TR CU 004, 020, 037) and consumables like gels or lotions (TR CU 009), optimizing both time and costs.

What happens if a product is borderline between cosmetic and medical?

In these cases, we perform a preliminary analysis to determine if EAC/SGR compliance is sufficient for the wellness market or if a full ministerial medical registration is mandatory.

Is RoHS (TR EAEU 037/2016) mandatory for aesthetic devices?

Yes. Since 2020, it has been mandatory to certify the absence of hazardous substances in all electronic aesthetic and wellness devices. Without this compliance, products are typically blocked at EAEU customs.

EAC Wellness & Aesthetic Equipment Certification

EAC Certification for Aesthetic, Wellness & Laboratory Equipment

EAC CERTIFICATION: AESTHETIC, WELLNESS & LABORATORY EQUIPMENT – Last update: 25.02.2026

Exporting to the wellness and diagnostics sector requires a fundamental distinction between clinical ministerial registration and mandatory technical and sanitary compliance for equipment and consumables. TechSert supports companies in certifying electrical apparatus (aesthetic lasers, lamps, laboratory instruments) according to EAC and RoHS standards, as well as the professional cosmetic products associated with them. For a broader view of regulatory requirements, please visit our EAC certifications main page.

1. ELECTRICAL SAFETY (TR CU 004, 020 & ROHS)

Every electrically powered device must pass rigorous testing to enter the EAEU market:

• SAFETY & COMPATIBILITY (LVD/EMC): Regulations TR CU 004 and 020 ensure the device is safe for the operator and does not create electromagnetic interference.
• ROHS REGULATION (TR EAEU 037/2016): Since 2020, it has been mandatory to certify the absence of hazardous substances in electronics. Without compliance with TR 037, products are blocked at customs.

2. COSMETIC PRODUCT CERTIFICATION (TR CU 009/2011)

Aesthetic equipment is often supplied with consumables such as creams, specific gels, or lotions. These fall under the TR CU 009/2011 regulation on the safety of cosmetic products.

Most of these products require an EAC Declaration, a procedure that certifies the safety of the composition and the accuracy of the labeling in the Russian language.

3. SGR: STATE REGISTRATION FOR SENSITIVE PRODUCTS

Certain “borderline” products in the wellness sector require higher vigilance through State Registration (SGR):

• SPECIALIZED COSMETICS: Including children’s products, intimate hygiene, or hair dyes.
• DIETARY SUPPLEMENTS: Food supplements and biologically active additives (BAA) sold within wellness centers.

4. WELLNESS COMPLIANCE FAQ

DOES TECHSERT MANAGE ROSZDRAVNADZOR REGISTRATION?
No. Our focus is on technical (EAC, RoHS) and sanitary (SGR, Cosmetics) compliance for free commercial circulation. We do not manage the clinical ministerial process for high-class medical devices.

CAN BOTH MACHINERY AND COSMETICS BE CERTIFIED TOGETHER?
Absolutely. We offer an integrated approach to certify the entire “sales package” (device + consumables), optimizing time, costs, and documentary analysis.

WHAT IF THE PRODUCT IS BETWEEN COSMETIC AND MEDICAL?
In these cases, we perform a preliminary analysis to determine if EAC/SGR compliance is sufficient or if the ministerial process is mandatory, guiding you to the fastest and most correct solution.

Analyze your Wellness & Aesthetic Product Compliance

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